A trial to evaluate an extended rehabilitation service for stroke patients EXTRAS News Issue 5: January 2015 Happy New Year from the EXTRAS co-ordinating centre! Here is some more EXTRAS news to share. 1. Likely new change to the EXTRAS recruitment period I m sure you will remember that we recently extended the EXTRAS recruitment period until 31 March 2015 but this was subject to further change. The recruitment period is now likely to be further extended to 30 June 2015. Whilst recruitment continues to go very well, to ensure that 510 patients are randomised to a treatment group, we need to recruit approximately 600 patients. We want to keep recruitment open until June 2015 to be sure we achieve this. We will confirm the new recruitment end date as soon as we can. For now, please keep recruiting! The yellow line shows remaining predicted recruitment Month 27 = Dec 2014 2. EXTRAS study centres The last EXTRAS study centre is now open. Cardiff opened to recruitment in December 2014. The team have hit the ground running, recruiting 1 participant in December and 7 in early January. Well done Cardiff! For all EXTRAS study centres see page 3. 3. Patient recruitment Recruitment continues to go very well. See pages 4 + 5 for centre recruitment numbers to end of December 2014. The total recruitment is 476 patients. In order to recruit 600 patients by June 2015, we need to recruit 25 patients per month. It would be really great if each centre could achieve their planned 2-4 patients per month as we head into these last few recruiting months. We ll be awarding a number of prizes to high recruiters in the next few months! Page 1 of 6
A trial to evaluate an extended rehabilitation service for stroke patients EXTRAS News Issue 5: January 2015 4. Delivery of the EXTRAS extended rehabilitation service This continues to go very well. Soon we re going to start to examine the data from the reviews so we can understand the types of rehabilitation issues being addressed. 5. Outcome assessments Jacky is now very busy doing both 12 and 24 month outcome assessments. Thanks to all of you who help Jacky with any details she needs. 6. EXTRAS data management Both Anne and Richard remain very busy behind the scenes with the EXTRAS data. The data quality is very good so thanks to everyone working to input the data and respond to co-ordinating centre queries. Jacky Price (outcome assessor) Richard Frances (database manager) Anne Harrison (project administrator) Page 2 of 6
A trial to evaluate an extended rehabilitation service for stroke patients EXTRAS News Issue 5: January 2015 Centres opened in EXTRAS project year 1 (Oct 2012 Sept 2013): 1. Northumbria Northumbria Healthcare NHS 2. Leeds Leeds Teaching Hospitals NHS Trust and Leeds Community Healthcare NHS Trust 3. Newcastle Newcastle upon Tyne Hospitals NHS 4. Pennine Pennine Acute Hospitals NHS Trust and Pennine Care NHS Foundation Trust 5. South Tyneside South Tyneside NHS 6. Cornwall Royal Cornwall Hospitals NHS Trust Centres opened in EXTRAS project year 2 (Oct 2013 Sept 2014): 7. Southampton/Solent Solent NHS Trust 8. Portsmouth/Solent Portsmouth Hospitals NHS Trust 9. Plymouth Plymouth Community Healthcare 10. Norfolk Norfolk Community Health and Care NHS Trust 11. Stafford Staffordshire and Stoke on Trent Partnership NHS Trust 12. Bournemouth Royal Bournemouth and Christchurch NHS Foundation Trust 13. Hull/Humber Hull and East Yorkshire NHS Trust and Humber NHS 14. York York Teaching Hospitals NHS 15. Sherwood Forest Sherwood Forest NHS 16. Somerset Somerset Partnership NHS 17. Wigan Wrightington, Wigan and Leigh NHS Foundation Centres opened in EXTRAS project year 3 (Oct 2014 Sept 2015): 18. Cardiff Cardiff and Vale University Health Board. Thanks to all recruiting, treating and admin staff at all EXTRAS study centres Page 3 of 6
Recruitment data to end of December 2014: centres 1-9 Northumbria Newcastle Leeds Pennine S Tyneside Cornwall S'ton/ Solent Portsmouth Plymouth Nov-12 2 Dec-12 3 3 Jan-13 1 1 2 Feb-13 2 0 1 0 Mar-13 2 2 7 2 Apr-13 3 2 4 1 May-13 3 1 5 1 Jun-13 5 1 3 0 Jul-13 1 1 5 1 Aug-13 6 0 5 1 2 1 Sep-13 1 2 4 3 1 4 Oct-13 3 0 5 1 0 5 0 Nov-13 5 0 5 1 3 1 2 0 3 Dec-13 1 0 7 0 0 3 1 2 5 Jan-14 1 2 10 1 3 2 1 1 4 Feb-14 2 0 4 2 1 1 2 1 4 Mar-14 4 0 9 1 1 2 1 0 5 Apr-14 2 1 0 0 1 6 2 1 4 May-14 2 0 4 0 3 4 3 0 3 Jun-14 2 0 4 0 1 3 1 0 4 Jul-14 3 2 4 0 0 1 3 1 3 Aug-14 4 0 4 0 1 6 3 0 3 Sept-14 3 1 4 2 0 4 1 1 4 Oct-14 1 0 2 0 2 3 0 1 3 Nov-14 1 3 5 1 2 2 0 2 1 Dec-14 0 0 3 1 0 3 0 1 2 Total 63 19 109 19 21 51 20 11 48 Page 4 of 6
Recruitment data to end of December 2014: centres 10-18 and total Norfolk Staffordshire Bournemouth Hull/Humber York Sherwood Somerset Wigan Cardiff Forest Total Nov-12 2 Dec-12 6 Jan-13 4 Feb-13 3 Mar-13 13 Apr-13 10 May-13 10 Jun-13 9 Jul-13 8 Aug-13 15 Sep-13 15 Oct-13 14 Nov-13 20 Dec-13 1 2 22 Jan-14 1 5 31 Feb-14 5 2 0 24 Mar-14 1 1 4 0 29 Apr-14 1 2 4 2 26 May-14 4 2 2 0 0 27 Jun-14 2 0 3 2 1 23 Jul-14 3 0 1 1 1 2 25 Aug-14 3 0 1 0 1 1 2 1 30 Sept-14 5 4 3 1 1 2 2 2 40 Oct-14 3 2 2 0 0 2 0 0 21 Nov-14 4 0 0 0 0 2 1 2 26 Dec-14 2 0 1 0 3 3 2 1 1 23 Total 35 20 21 6 7 12 7 6 1 476 Page 5 of 6
What is EXTRAS? EXTRAS is a clinical trial to evaluate a new longer term stroke rehabilitation service. One third of patients have long term disability after stroke but specialist stroke rehabilitation usually last no more than a few months. Patients who have on going rehabilitation needs once specialist stroke rehabilitation finishes may be referred to a range of other health care professionals or services, but most do not offer specialist stroke rehabilitation. One of the reasons why specialist stroke rehabilitation is not provided over a longer period is because it is not yet known if it is beneficial. The EXTRAS clinical trial will determine whether a new extended stroke rehabilitation service is beneficial to patients and carers. Stroke patients and carers who agree to participate in the trial are randomly allocated to either receive a new extended stroke rehabilitation service or continue with usual NHS care. The new extended rehabilitation service begins when routine Early Supported Discharge (ESD) ends. It involves on going contact, usually by telephone, with a senior ESD stroke therapist or nurse for 18 months after ESD finishes. A senior stroke therapist or nurse will contact patients and carers at 1, 3, 6, 12 and 18 months after discharge from ESD to review their progress and rehabilitation needs. Rehabilitation goals will be agreed and the therapist or nurse will give advice on how to progress towards these goals. The advice may be verbal advice, for example, exercises to practice at home, or, if required, referral to local rehabilitation services may be arranged. The effectiveness of the new extended rehabilitation service will be evaluated by comparing the health (e.g. functional abilities and quality of life) of patients and carers who received the new service with those who received usual NHS care. EXTRAS Contacts Professor Helen Rodgers, Chief Investigator Helen.Rodgers@ncl.ac.uk 0191 208 6779 Dr Lisa Shaw, Co-investigator and Project Manager Lisa.Shaw@ncl.ac.uk 0191 208 3826 Miss Anne Harrison, Project Administrator Anne.Harrison@ncl.ac.uk 0191 208 3853 This project is funded by the NIHR Health Technology Assessment programme (project number 10/37/01). The views and opinions expressed here are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or Department of Health. Page 6 of 6